BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17686551 · Received September 5, 2023

    Report

    Report Number
    2916596-2023-06169
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 13, 2023
    Report Date
    October 31, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: REPORTER PHONE NUMBER WAS UNAVAILABLE, REPORTER ADDRESS - (B)(6) MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A DRIVELINE POWER FAULT ALARMS WAS CONFIRMED. THE MODULAR CABLE (LOT NUMBER: 7102957) WAS RETURNED FOR ANALYSIS, AND LOG FILES WERE REVIEWED WHICH SHOWED OVERLAPPING EVENTS SPANNING APPROXIMATELY 11 DAYS ((B)(6) 2023 ¿ (B)(6) 2023, (B)(6) 2023 PER TIMESTAMP). ON (B)(6) 2023 AT 20:06:21, DRIVELINE POWER FAULT ALARMS WERE ACTIVE DUE TO A POWER A BROKEN FAULT. THE FAULT ACTIVATED TWICE MORE BEFORE CLEARING; HOWEVER, THE ALARM REMAINED LATCHED UNTIL 20:40:14 ON (B)(6) 2023. THE ALARM DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. THE DRIVELINE WAS DISCONNECTED FROM CONTROLLER ON (B)(6) 2023 AT 20:40:15; WHICH IS CONSISTENT A CONTROLLER EXCHANGE. NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. THE MODULAR CABLE WAS FUNCTIONALLY TESTED WITH BOTH THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) AND A TEST SYSTEM CONTROLLER ON A MOCK LOOP FOR EXTENDED OPERATION DURING WHICH THE CABLE WAS MANIPULATED BY HAND WITH NO ALARMS ACTIVE. RESISTANCE TESTING WAS PERFORMED ON THE UNDERLYING WIRES, AND IT WAS FOUND THAT THE BROWN WIRE (POWER A) HAD FLUCTUATING RESISTANCES, WHEN MANIPULATED BY HAND. THE CABLE¿S OUTER JACKET WAS STRIPPED, AND THE BROWN WIRE WAS OBSERVED TO BE SEVERELY DAMAGED. THE CABLE WAS CONNECTED TO A TEST SYSTEM CONTROLLER AND MOCK LOOP AND A DRIVELINE POWER FAULT ALARM BECAME ACTIVE. FURTHER INSPECTION REVEALED THE BROWN WIRE TO BE SEVERED. THE OBSERVED DAMAGE TO THE BROWN UNDERLYING WIRE RESULTED IN THE REPORTED ALARM. THE ROOT CAUSE FOR THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE DUE TO WIRE FATIGUE OF THE MODULAR CABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 VAD MODULAR CABLE (SERIAL NUMBER: (B)(6)) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING DRIVELINE POWER FAULT ALARMS. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 2 - ¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 2 - ¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXCHANGED THEIR SYSTEM CONTROLLER AT HOME DUE TO A DRIVELINE POWER FAULT ALARM WHICH TEMPORARILY RESOLVED THE ALARM. THE PATIENT WENT TO THE HOSPITAL AND THE ALARM REOCCURRED. THE MODULAR CABLE WAS EXCHANGED, AND THE DRIVELINE POWER FAULT ALARM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974404 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 7102957 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown